Zoledronic Acid in Acute Spinal Cord Injury
|ClinicalTrials.gov Identifier: NCT01642901|
Recruitment Status : Active, not recruiting
First Posted : July 17, 2012
Last Update Posted : November 13, 2017
|Condition or disease||Intervention/treatment||Phase|
|Spinal Cord Injury||Drug: Zoledronic acid Drug: normal saline 0.9%||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Zoledronic Acid to Prevent Bone Loss After Acute Spinal Cord Injury|
|Study Start Date :||May 2012|
|Estimated Primary Completion Date :||June 2018|
|Estimated Study Completion Date :||June 2018|
Experimental: Zoledronic Acid 5 mg IV infusion
Single infusion of 5 mg intravenous zoledronic acid given within 21 days of acute traumatic spinal cord injury.
Drug: Zoledronic acid
5 mg zoledronic acid infused intravenously over two hours (2.5mg per hour), given only once, within 21 days of acute traumatic spinal cord injury.
Other Name: Reclast
Placebo Comparator: normal saline 0.9%
Infusion of normal saline of equivalent volume to reconstituted zoledronic acid, given only once and run over 2 hours, to occur within 21 days of acute traumatic spinal cord injury.
Drug: normal saline 0.9%
Infusion of equivalent volume of 0.9% normal saline to that of the reconstituted zoledronic acid, given only once over two hours, occurring within 21 days of acute traumatic spinal cord injury
- change in bone mineral density [ Time Frame: one year ]
Change in bone mineral density (BMD) assessed by dual energy X-ray absorptiometry (DXA) at baseline, 4 months, and 12 months post-injury.
This will compare BMD at the hip, distal femur and proximal tibia.
- Biomarkers of bone formation and resorption [ Time Frame: Baseline, 1 month, 4 month, and 12 months ]
Collection of blood biomarkers of bone formation and resorption at selected time intervals within the first 12 months post-injury.
This will observe the timing of metabolic indexes of bone formation and resorption, and of pro-osteoclastogenic factors promoting bone resorption.
- safety and tolerability of zoledronic acid [ Time Frame: one year ]Assessment of the safety and tolerability of zoledronic acid in the acute spinal cord injury population. This will be done by examination reportable adverse events including fevers, flu-like symptoms, GI upset as measures of safety and report of patient's willingness to have participate in physical therapy in the first week after receiving medication as a measure of tolerability
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01642901
|United States, Pennsylvania|
|Thomas Jefferson University and Hospital|
|Philadelphia, Pennsylvania, United States, 19107|
|Principal Investigator:||Christina V Oleson, MD||Thomas Jefferson University|